External fixation strut

ABSTRACT

Embodiments of the invention include an external fixation system that includes at least one external fixation strut that is both acutely adjustable and precisely adjustable and related methods of adjustment. Acute adjustment may be accomplished using one or more mobile jaws that may be engaged with or disengage from a threaded rod of each external fixation strut. Precise adjustment of each external fixation strut may be accomplished after releasing a lock biased toward a locked position. When each external fixation struts lock is released, a portion of each of the precise adjustment mechanism of each external fixation strut may be activated to increase and decrease the length of each of the at least one external fixation struts.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a United States National Phase filing ofInternational Application No. PCT/US2019/057339, filed Oct. 22, 2019,which claims the benefit of U.S. Provisional Patent Application No.62/752,671, filed Oct. 30, 2018, entitled “External Fixation Strut,” theentire contents of which applications are hereby incorporated byreference in their entirety.

FIELD OF THE INVENTION

The present disclosure relates generally to the field of orthopedicimplants, and more particularly but not exclusively relates toorthopedic external fixation devices and related methods.

BACKGROUND

External fixation devices have been successfully used in orthopedics fora long time. Hexapod systems in particular have proven to be valuableclinical tools for treating a variety of conditions. One well knownhexapod system is the Taylor Spatial Frame (TSF) by Smith and Nephew.The TSF has demonstrated clinical success for decades and has inspireddevelopment of many similar systems.

In general, orthopedic hexapods may include first and second bases,which may generally be in the form of rings, fixation components, and upto six variable length struts. The fixation components are connected toeach of the bases to secure the bases to the patient's bone fragments.The six struts connect the two bases to one another and allow forprecise manipulation of the bases, and hence the patient's bonefragments, in six degrees of freedom.

Generally speaking, in the most basic sense, the variable length strutsinclude a strut body, a threaded rod, and a mechanism for adjustment. Inuse, the threaded rod may translate relative to the strut body to changethe overall length of the strut. Thus arranged, by individuallyadjusting each of the struts, manipulation of the relative positions ofthe first and second bases, and hence the patient's bone fragmentscoupled thereto is possible. Patients or caregivers adjust the strutlengths according to a computer-generated prescription to achieve adesired correction.

Medical device companies have been developing external fixation strutswith additional telescopic bodies, various acute and precise adjustmentmechanisms, and assorted joint designs.

It is with respect to these and other considerations that the presentimprovements may be useful.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended asan aid in determining the scope of the claimed subject matter.

An external fixation strut is disclosed. In one example of anembodiment, the external fixation strut comprises a strut bodyoperatively associated with a first connector, a threaded rod includingthreads formed thereon, the threaded rod being operatively associatedwith a second connector, and an acute adjustment mechanism selectivelydisengageable from the threads of the threaded rod. In use, the threadedrod is rotationally fixed relative to the strut body so that movement ofthe threaded rod relative to the strut body moves the first connectorrelative to the second connector. The acute adjustment mechanismcomprises an actuator body, a mobile jaw that is engageable with thethreads of the threaded rod, and a disengagement member configured tointeract with the mobile jaw to disengage the mobile jaw from thethreads of the threaded rod. In use, the disengagement member isselectively movable from a first position to a second position such thatwhen in the second position, the disengagement member interacts with themobile jaw to disengage the mobile jaw from the threads of the threadedrod to enable the first and second connectors to be adjusted acutely.

In some embodiments, the mobile jaw includes a threaded surfaceconfigured to engage with the threads of the threaded rod.

In some embodiments, the acute adjustment mechanism includes twosubstantially oppositely positioned mobile jaws configured to engagewith threads of the threaded rod on substantially opposite sides of thethreaded rod.

In some embodiments, the substantially oppositely positioned mobile jawseach include a threaded surface configured to engage with threads of thethreaded rod.

In some embodiments, the mobile jaw is biased to engage with thethreaded rod.

In some embodiments, the mobile jaw is biased to disengage from thethreaded rod.

In some embodiments, the disengagement member is a button configured tointeract with the mobile jaw to disengage the mobile jaw from thethreads of the threaded rod when the button is moved by a user from thefirst position to the second position.

In some embodiments, the button includes an angled face configured tointeract with one or more faces of the mobile jaw to disengage themobile jaw from the threads of the threaded rod.

In some embodiments, the disengagement member is configured to translatetoward the mobile jaw when moved from the first position to the secondposition to disengage the mobile jaw from the threaded rod and thedisengagement member is configured to rotate about the disengagementmember's axis of translation to lock the acute adjustment mechanism in astate of free movement where the mobile jaw is disengaged from thethreaded rod.

In some embodiments, the disengagement member is configured to translateaway from the mobile jaw when moved from the first position to thesecond position to enable the mobile jaw to disengage from the threadedrod.

In some embodiments, the disengagement member includes a containmentdevice configured to prevent the mobile jaw from moving away from thethreads of the threaded rod when the containment device is coupled tothe acute adjustment mechanism.

In some embodiments, the containment device is arranged and configuredas an ID band for identifying each respective strut.

In some embodiments, the mobile jaw is configured to translate away fromthe threaded rod when interacted with by the disengagement member.

In some embodiments, the mobile jaw is configured to pivot away from thethreaded rod when interacted with by the disengagement member.

In some embodiments, the actuator body includes a threaded collar thatcouples the actuator body with the strut body.

In some embodiments, the actuator body includes channels configured toguide the movement of the mobile jaw when the mobile jaw is interactedwith by the disengagement member.

In some embodiments, the actuator body includes channels configured toconstrain the movement of protrusions on the mobile jaw when the mobilejaw is interacted on by the disengagement member.

In some embodiments, the mobile jaw has one or more angled facesconfigured to interact with the disengagement member to move the mobilejaw away from the threaded rod.

In some embodiments, the external fixation strut further comprises arotatable sleeve that is sized to fit over the outside of the actuatorbody with one or more openings for access to the disengagement member.

In some embodiments, when the rotatable sleeve is rotated relative tothe actuator body, access to the disengagement member is blocked.

In some embodiments, when the rotatable sleeve is rotated relative tothe actuator body a portion of opening interacts with the disengagementmember to disengage the mobile jaw from the threaded rod.

In some embodiments, the external fixation strut further comprises aprecise adjustment mechanism comprising a lock positioned between thestrut body and the actuator body; wherein the lock is movable between afirst position and a second position, in the first position, the lock isarranged and configured to rotationally fix the strut body relative tothe actuator body in the second position, the lock is arranged andconfigured to enable rotation of the actuator body relative to the strutbody to move the threaded rod longitudinally relative to the strut body.

In some embodiments, the lock of the precise adjustment mechanismincludes a base coupled to the strut body, a plunger biased away fromthe base, and a cavity formed in the actuator body, the cavity arrangedand configured to receive the plunger to restrict rotational movement ofthe strut body relative to the actuator body.

In some embodiments, the lock of the precise adjustment mechanismincludes a pivot coupled to the actuator body, the pivot being biasedtoward the strut body and being arranged and configured to fit in anotch formed in the strut body to restrict rotational movement of thestrut body relative to the actuator body when a portion of the pivot ispositioned in the notch in the strut body.

In some embodiments, the actuator body includes openings for receivingprojections of a band to prevent disengagement of the mobile jaw fromthe threaded rod.

In some embodiments, the external fixation strut further comprises aband, wherein the band is arranged and configured to cover thedisengagement member when the band is positioned on the acute adjustmentmechanism to prevent access to the disengagement member.

In some embodiments, the first and second connectors are first andsecond U-joints, respectively, the first and second U-joints includingfirst and second devises, a central body having a plurality of threadedopenings, and a plurality of set screws arranged and configured tocouple the central body to the first and second joint devises.

In some embodiments, the external fixation strut further comprises atracer pin operatively coupled to the threaded rod and a locking sleeveoperatively coupled to the strut body, the locking sleeve including anopening arranged and configured to receive the tracer pin, the lockingsleeve being arranged and configured to prevent movement of the trackpin and thus to prevent adjustment of the external fixation strut.

An alternate embodiment of an external fixation strut may include astrut body, a threaded rod substantially rotationally fixed relative tothe strut body, an acute adjustment mechanism, and an optional preciseadjustment mechanism comprising a lock between the strut body and theactuator body. The acute adjustment mechanism may be selectivelydisengageable from threads of the threaded rod and include an actuatorbody, a mobile jaw that is engageable with the threads of the threadedrod, and a disengagement member configured to interact with the mobilejaw to disengage the mobile jaw from the threads of the threaded rod.The lock may be biased to fix the strut body with the actuator bodyrotationally, but may be activated to allow for rotation of the actuatorbody relative to the strut body to move the threaded rod longitudinallyrelative to the strut body.

Another embodiment of an external fixation system may include an upperbase, a lower base, and at least two struts coupled between the upperbase and the lower base. At least one of the struts includes a strutbody, a threaded rod substantially rotationally fixed relative to thestrut body, and an acute adjustment mechanism selectively disengageablefrom the threads of the threaded rod. The acute adjustment mechanism mayinclude an actuator body, a mobile jaw that is engageable with thethreads of the threaded rod, and a disengagement member configured tointeract with the mobile jaw to disengage the mobile jaw from thethreads of the threaded rod. At least one of the struts may optionallyinclude a precise adjustment mechanism comprising a lock between thestrut body and the actuator body. The lock may be biased to fix thestrut body with the actuator body rotationally, but may be activated toallow for rotation of the actuator body relative to the strut body tomove the threaded rod longitudinally relative to the strut body.

Still another embodiment is directed to a method of adjusting anexternal fixation strut. The method may include disengaging an acuteadjustment mechanism of the external fixation strut from threads of athreaded rod of the external fixation strut, wherein the acuteadjustment mechanism is biased toward an engaged state, and wherein thethreaded rod is substantially rotationally fixed relative to a strutbody of the external fixation strut, and moving the acute adjustmentmechanism relative to the threaded rod to a position closer to a finaladjustment position. The method may also include engaging the acuteadjustment mechanism of the external fixation strut to the threads ofthe threaded rod by removing force against the bias toward an engagedstate, releasing a lock of a precise adjustment mechanism that isconfigured to lock between the strut body and the acute adjustmentmechanism, and with the lock of the precise adjustment mechanism in areleased state, rotating the acute adjustment mechanism relative to thestrut body to move the threaded rod longitudinally relative to the strutbody.

Yet another embodiment is directed to a method of adjusting an externalfixation strut. The method may include disengaging an acute adjustmentmechanism of the external fixation strut from threads of a threaded rodof the external fixation strut, wherein the acute adjustment mechanismis biased toward a disengaged state, and wherein the threaded rod issubstantially rotationally fixed relative to a strut body of theexternal fixation strut. The method may include moving the acuteadjustment mechanism relative to the threaded rod to a position closerto a final adjustment position, engaging the acute adjustment mechanismof the external fixation strut to the threads of the threaded rod byapplying force against the bias toward a disengaged state, and releasinga lock of a precise adjustment mechanism that is configured to lockbetween the strut body and the acute adjustment mechanism. With the lockof the precise adjustment mechanism in a released state, the acuteadjustment mechanism may be rotated relative to the strut body to movethe threaded rod longitudinally relative to the strut body.

Embodiments of the present disclosure provide numerous advantages. Byincorporating an acute adjustment mechanism including one or more mobilejaws and a disengagement member, the external fixation strut facilitatesgross adjustment of the length of the strut for acute adjustment andsimplified installation and removal. In addition, the embodimentsdisclosed within the present disclosure describe a new strut designwhich focuses on safety with features impeding accidental adjustment ofthe acute and precise adjustment mechanisms. The embodiment of thepresent disclosure also focus on efficiency with components configuredto preserve the maximum amount of working length on the threaded rod.

Further features and advantages of at least some of the embodiments ofthe present invention, as well as the structure and operation of variousembodiments of the present invention, are described in detail below withreference to the accompanying drawings

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a perspective view of an example of an embodiment ofan external fixation strut in accordance with principles of the presentdisclosure.

FIG. 1B illustrates a back elevation view of the external fixation strutshown in FIG. 1A.

FIG. 1C illustrates a front elevation view of the external fixationstrut shown in FIG. 1A.

FIG. 2 illustrates an exploded, perspective view of the externalfixation strut shown in FIG. 1A.

FIG. 3A illustrates a detailed, front elevation view of an example of anembodiment of an acute adjustment mechanism that can be used incombination with the external fixation strut shown in FIG. 1A.

FIG. 3B illustrates a detailed, back elevation view of the acuteadjustment mechanism shown in FIG. 3A.

FIG. 3C illustrates a front elevation view of the acute adjustmentmechanism shown in FIG. 3A, the acute adjustment mechanism shown with aband removed to illustrate a rotating sleeve.

FIG. 3D illustrates a front elevation view of the acute adjustmentmechanism shown in FIG. 3C with the rotating sleeve rotatedcounterclockwise.

FIG. 3E illustrates a cross-sectional view of the acute adjustmentmechanism shown in FIG. 3C, the acute adjustment mechanism includingthreads engaged with a threaded rod.

FIG. 3F illustrates a cross-sectional view of the acute adjustmentmechanism shown in FIG. 3D, the acute adjustment mechanism shown withits threads disengaged from the threaded rod.

FIG. 4 illustrates an exploded, perspective view of an example of anembodiment of a band for use with the external fixation strut shown inFIG. 1A.

FIG. 5A illustrates an exploded, perspective view of an example of anembodiment of the acute adjustment mechanism that may be used incombination with the external fixation strut shown in FIG. 1A.

FIG. 5B illustrates an alternate, exploded, perspective view of theacute adjustment mechanism shown in FIG. 5A.

FIG. 6A illustrates a side elevation view of an example of an embodimentof a precise adjustment mechanism that may be used in combination withthe external fixation strut shown in FIG. 1A, the precise adjustmentmechanism including a plunger positioned in a locked position.

FIG. 6B illustrates a side elevation view of the precise adjustmentmechanism shown in FIG. 6A, the precise adjustment mechanism includingthe plunger positioned in an unlocked position.

FIG. 6C illustrates an exploded, perspective view of the preciseadjustment mechanism shown in FIG. 6A and a portion of the acuteadjustment mechanism shown in FIG. 5B.

FIG. 7A illustrates a perspective view of an example of an embodiment ofa universal joint that may be used in combination with an externalfixation strut.

FIG. 7B illustrates an exploded, perspective view of the universal jointshown in FIG. 7A.

FIG. 8A illustrates a top plane view of an example of an embodiment ofan angled button that may be in combination with the external fixationstrut shown in FIG. 1A.

FIG. 8B illustrates a top plane view of an example of an embodiment of arounded button that may be in combination with the external fixationstrut shown in FIG. 1A.

FIGS. 9A and 9B illustrate an example of an embodiment of an externalfixation strut with the rounded button of FIG. 8B, the rounded buttonillustrated in a non-activated or non-pushed position, and consequentlythe acute adjustment mechanism is engaged with the threaded rod.

FIGS. 9C and 9D illustrate an example of an embodiment of an externalfixation strut with the rounded button of FIG. 8B, the rounded buttonillustrated in an activated or pushed position, and consequently, theacute adjustment mechanism is disengage with the threaded rod, andadditionally the rotating sleeve has been rotated.

FIG. 10 illustrates a perspective view of an example of an embodiment ofa locking sleeve coupled to the external fixation strut shown in FIG.1A.

FIG. 11A illustrates a perspective view of an alternate example of anexternal fixation strut in accordance with principles of the presentdisclosure.

FIG. 11B illustrates a back elevation view of the external fixationstrut shown in FIG. 11A.

FIG. 11C illustrates a front elevation view of the external fixationstrut shown in FIG. 11A.

FIG. 12 illustrates an exploded, perspective view of the externalfixation strut shown in FIG. 11A.

FIG. 13A illustrates a side elevation view of an example of anembodiment of an acute adjustment mechanism that can be used incombination with the external fixation strut shown in FIG. 11A.

FIG. 13B illustrates a side elevation view of the acute adjustmentmechanism shown in FIG. 13A with a band removed.

FIG. 13C illustrate an opposite side elevation view of the acuteadjustment mechanism shown in FIG. 13B with a button pushed.

FIG. 13D is a cross-sectional view of the acute adjustment mechanismshown in FIG. 13B.

FIG. 13E is a cross-sectional view of the acute adjustment mechanismshown in FIG. 13C.

FIG. 14A is a side elevation view of the acute adjustment mechanismshown in FIG. 13E with the button rotated counterclockwise, as well aspushed.

FIG. 14B is a perspective view of the acute adjustment mechanism shownin FIG. 14A with the actuator body of the device removed to viewinternal components of the mechanism.

FIG. 15A is a perspective view of the acute adjustment mechanism shownin FIG. 14A showing a portion of an example of an embodiment of aprecise adjustment mechanism.

FIG. 15B is a perspective view of the acute adjustment mechanism shownin FIG. 15A with the band removed.

FIG. 15C is a perspective view of the acute adjustment mechanism shownin FIG. 15B with the actuator body of the device removed to viewinternal components of the mechanism.

FIG. 15D is a perspective view of the acute adjustment mechanism shownin FIG. 15B with the precise adjustment mechanism in an unlockedposition.

FIG. 15E is a perspective view of the acute adjustment mechanism shownin FIG. 15D with the actuator body of the device removed to viewinternal components of the mechanism.

FIG. 16 is a perspective view of an interior portion of the acuteadjustment mechanism shown in FIG. 15A.

FIG. 17 is a perspective view of an alternate example of an embodimentof an external fixation strut in accordance with principles of thepresent disclosure.

FIG. 18A is a top, perspective view of the external fixation strut shownin FIG. 17, the view illustrating an example of an embodiment of anacute adjustment mechanism and band.

FIG. 18B is a perspective view of the acute adjustment mechanism shownin FIG. 18A with the actuator body of the device removed to viewinternal components of the mechanism.

FIG. 18C is a perspective view of the acute adjustment mechanism shownin FIG. 18A with the band removed.

FIG. 18D is a perspective view of the acute adjustment mechanism shownin FIG. 18C with a portion of the device removed to view internalcomponents of the mechanism.

FIG. 19 is a perspective view of an alternate example of an embodimentof an external fixation strut in accordance with principles of thepresent disclosure.

FIG. 20A is a top, perspective view of the external fixation strut shownin FIG. 19, the view illustrating an example of an embodiment of anacute adjustment mechanism and band.

FIG. 20B is a perspective view of the acute adjustment mechanism shownin FIG. 20A with the band removed.

FIG. 20C is a perspective view of the band shown in FIGS. 20A and 20B.

FIG. 20D is a perspective view of the acute adjustment mechanism shownin FIGS. 20A and 20B with the actuator body of the device removed toview internal components of the mechanism.

FIG. 20E is a perspective view of the acute adjustment mechanism shownin FIGS. 20A and 20B with a portion of the device removed to viewinternal components of the mechanism.

FIG. 20F is a top, perspective view of the external fixation strut shownin FIG. 19, the view illustrating the acute adjustment mechanism andshowing the disengagement member in an activated position.

FIG. 20G is a perspective view of the acute adjustment mechanism shownin FIG. 20F with the actuator body of the device removed to viewinternal components of the mechanism.

FIG. 21A is a perspective view of most components of the acuteadjustment mechanism shown in FIG. 20F with a temporary or acute bandinstalled to hold the disengagement member in an activated position.

FIG. 21B is a perspective view of the temporary or acute shown in FIG.21A.

FIG. 22A is a perspective view of an alternate example of an embodimentof a temporary or acute band that may be used with the eternal fixationstrut;

FIG. 22B is a top view of the temporary or acute band shown in FIG. 22A.

FIG. 22C is a bottom view of the temporary or acute band shown in FIG.22A.

FIG. 22D is a side view of the temporary or acute band shown in FIG.22A.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the figures and specific language will be used todescribe the same. The external fixation struts of the presentdisclosure may, however, be embodied in many different forms and shouldnot be construed as being limited to the embodiments set forth herein.Rather, these embodiments are provided so that this disclosure willconvey certain aspects of the external fixation struts to those skilledin the art. As such, it will be understood that no limitation of thescope of the present disclosure is hereby intended. Any alterations andfurther modifications in the described embodiments, and any furtherapplications of the principles of the present disclosure as describedherein are contemplated as would normally occur to one skilled in theart to which the disclosure relates. In the drawings, like numbers referto like elements throughout unless otherwise noted.

Referring to FIGS. 1A-10, in one example of an embodiment, an externalfixation strut 100 is disclosed. As shown in the example embodiment, theexternal fixation strut 100 may include a strut body 110, a threaded rod120 substantially rotationally fixed relative to the strut body 110 sothat movement of the threaded rod 120 axially translates or moves thethreaded rod 120 relative to the strut body 110 (e.g., movement of thethreaded rod 120 is limited to translation relative to the strut body110), an acute adjustment mechanism 200 selectively disengageable fromthreads of the threaded rod 120, and a precise adjustment mechanism 300.

In one example of an embodiment, the acute adjustment mechanism 200includes an actuator body 210 that includes a threaded collar 250, aspring-loaded mobile jaw 220 including associated biasing springs 214,and one or more disengagement members 230 that are configured tointeract with the mobile jaw 220. As shown, the actuator body 210 mayinclude apertures 216 to receive at least a portion of the disengagementmembers 230. The disengagement members 230 may be in the form of one ormore buttons, but other embodiments are envisioned including, forexample, one or more wedges, screws, cams, or any other mechanism nowknown or hereafter developed.

In the illustrated embodiment, the external fixation strut 100 may alsoinclude a rotating sleeve 240. In use, the rotating sleeve 240 isarranged and configured to fit over the outside of the actuator body210. The rotating sleeve 240 may include openings 260 to provide accessto the disengagement members 230 for reasons that will be described ingreater detail below.

The threaded collar 250 is arranged and configured to couple theactuator body 210 to the strut body 110. In one example of anembodiment, the actuator body 210 may include one or more channels 212(FIG. 5B) to guide the path of the mobile jaws 220 and the associatedsprings 214. In use, the associated springs 214 bias the mobile jaws 220against the threaded rod 120 and toward the disengagement members 230.For example, the mobile jaws 220 have faces 222 that interact withsurfaces 232 of the disengagement members 230 so that when thedisengagement members 230 are pressed inward, the mobile jaws 220 move(e.g., separate and disengage) from the threaded rod 120 so that thestrut length of the external fixation strut 100 can be adjusted acutely.In use, the acute adjustment mechanism 200 facilitates gross adjustment.For example, when installing an external fixation system, a surgeon mayinitially implant the external fixation system with the acute adjustmentmechanism 200 disengaged from the threaded rod 120 (e.g., the mobilejaws 220 may be disengaged from the threaded rod 120). Thus arranged,the surgeon can correct the patient's deformity acutely (making grosscorrections in the operating room). Once the surgeon has completedplacing, positioning, implanting, etc. the external fixation system, theacute adjustment mechanism 200 may be moved to the activated, coupled,etc. position so that the acute adjustment mechanism 200 engages thethreaded rod 120 (e.g., mobile jaws 220 engage the threaded rod 120) tolock, fix, etc. the position of the external fixation struts.Thereafter, the struts can be adjusted in small increments using theprecise adjustment mechanism 300, for example, by the patient inconnection with daily adjustments needed to comply with theprescription.

In one example of an embodiment, as shown, the precise adjustmentmechanism 300 includes a body 310, a plunger 320, and a spring 330. Thespring 330 biases the plunger 320 to an extended position beyond anouter edge 312 of the body 310 and into a cavity 252 of the threadedcollar 250. The body 310 cannot turn as long as a portion of the plunger320 is in the cavity 252 of the threaded collar 250.

In one example of an embodiment, as shown, the external fixation strut100 may also include bands 400, as will be described herein. Inaddition, and/or alternatively, the external fixation strut 100 may alsoinclude and one or more connectors 500 to couple the external fixationstrut 100 to one or more bases, as will be described in greater detailbelow. In use, the connectors 500 may be in the form of a Universaljoint (U-joint) as shown, alternatively however any other now known orhereafter developed connector can be used such as, for example, balljoints, threaded ends, etc.

Referring to FIGS. 3A-3F and 5A-5B, the acute adjustment mechanism 200will be described in greater detail. The channels 212 formed in theactuator body 210 that guide the path of the mobile jaws 220 and theirsprings 214 are illustrated in FIGS. 3E, 3F, and 5B. In the illustratedembodiment, the acute adjustment mechanism 200 includes first and secondmobile jaws 220. In use, the first and second mobile jaws 220 are biasedto couple with the threads of the threaded rod 120 by the springs 214.The mobile jaws 220 shown include threaded portions that interact withthe threaded rod 120, but in other embodiments, mobile jaws may includeother structure for interacting with the threaded rod including, forexample, knurling, a softer material, or any other structure or materialthat is capable of interacting with the threads of the threaded rod 120.In use, the mobile jaws 220 may also be arranged and configured tointeract with the disengagement members 230. For example, the mobilejaws 220 may include faces 222 that interact with surfaces 232 of thedisengagement members 230. Apertures 216 (FIGS. 5A and 5B) formed in thesides of the actuator body 210 may constrain the two opposingdisengagement members 230. In use, the disengagement members 230 aredesigned so that they can be pressed from outside of the actuator body210 toward the threaded rod 120 so that when the disengagement members230 are pressed inward, the mobile jaws 220 disengage from the threadedrod 120 enabling the strut length of the external fixation struts 100 tobe adjusted acutely. For example, in one embodiment, the geometry of thedisengagement members 230 inside of the actuator body 210 may be shapedlike a wedge, although other suitable configurations are envisioned. Thefaces 232 of this wedge interact with the faces 222 of the mobile jaws220 so that when the disengagement members 230 are pressed inward, themobile jaws 220 move (e.g., separate and disengage) from the threadedrod 120 (FIG. 3F) enabling the threads formed on the mobile jaws 220 tobe disengaged from the threads formed on the threaded rod 120 and thusenable the strut length to be adjusted acutely.

The mobile jaws 220 may be constrained within the actuator body 210 bythe channel 212 formed in the actuator body 210 (FIGS. 3E, 3F, and 5B)so that translation toward and away from the threaded rod 120 isaccomplished without any rotation. As previously mentioned, the externalfixation strut 100 may also include a rotating sleeve 240 that fits overthe outside of the actuator body 210 with openings 260 for providingaccess to the disengagement members 230. In use, rotating the sleeve 240depresses the disengagement members 230 and locks the disengagementmembers 230 in the depressed position. Thus arranged, the rotatingsleeve 240 allows for multiple struts to be adjusted acutely at oncebecause the user is not required to keep the disengagement members 230depressed by hand.

As previously mentioned, the external fixation strut 100 may alsoinclude a threaded collar 250. In use, the threaded collar 250 connectsthe actuator body 210 to the strut body 110. The threaded collar 250 maybe slid up the base of the strut body 110 and threaded into the base ofthe actuator body 210. As shown, the acute adjustment mechanism 200 mayalso include a first washer 280 and a second washer 282 (FIG. 2).Washers 280, 282 may be positioned between the threaded collar 250 andthe strut body 110, and between the strut body 110 and the actuator body210. The washers 280, 282 act as spacers and reduce friction. The washer282 between the strut body 110 and the actuator body 210 may alsofurther constrain the mobile jaws 220 and disengagement members 230. Themobile jaws 220 may be constrained within the acute adjustment mechanism200 by the channels 212. The channels 212 inside the actuator body 210may correspond to (substantially match) a rectangular protrusion 224(FIGS. 5A and 5B) on the top of the mobile jaws 220. In use, thisconstrains the mobile jaws 220 to translation toward and away from thethreaded rod 120 and prevents the mobile jaws 220 from rotating out ofposition. Alternatively, the mobile jaws of some embodiments may haveposts on the jaws that align with holes on the actuator body and therotating sleeve.

Referring to FIG. 4, as previously mentioned, the external fixationstrut 100 may also include a band 400. In some embodiments, the bands400 may be arranged and configured as an identification (ID) band foridentifying each particular strut in the external fixation system. Assuch, the bands 400 may be provided to numerically identify strutassemblies so that each strut assembly may be distinguished for aprescription. In use, the bands 400 are coupled to the external fixationstruts 100. For example, as shown, in one example of an embodiment, theband 400 may be slid down over the top of the actuator body 210 by theaction arrows in FIG. 4. Pegs, projections, etc. 410 on the band 400 aresized and configured to be received by holes 218 formed in the actuatorbody 210. In use, the pegs, projections, etc. 410 prevent the mobilejaws 220 from disengaging from the threaded rod 120 when the band 400 iscoupled to the actuator body 210. In the illustrated embodiment, theband 400 has a body 420 which covers the disengagement members 230 sothat the buttons are not accessible when the band 400 is positioned overthe actuator body 210. In some embodiments, the body 420 may include aspace, a slot, a channel, or the like 430 to receive a tab, aprojection, or the like 242 (FIGS. 5A and 5B) of the rotating sleeve240.

The band 400 provides a safety feature and reduces the risk ofinadvertent acute adjustment of the strut assembly by inhibiting accessto the disengagement members 230 (e.g., inhibits accidental pressing ofthe buttons). Holes, pegs, and geometric features on the band, actuatorbody, and rotating sleeve may also or alternatively be used to provideeasy placement of the band in the proper orientation. Acute adjustmentgenerally takes place clinically during application of the externalfixation frame or during strut change-outs. The bands 400 may be helpfulto avoid inadvertent acute adjustment when a patient is adjusting strutsusing precise adjustment mechanisms to comply with an adjustmentprescription such as, for example, when adjusting the struts at homeutilizing a precise adjustment mechanism to comply with theprescription.

Referring to FIGS. 6A-6C, the precise adjustment mechanism 300 will bedescribed in greater detail. As will be described in greater detail, theprecise adjustment mechanism 300 enables the strut length of theexternal fixation struts 100 to be adjusted. For example, as previouslymentioned, the precise adjustment mechanism 300 may be used by patientsduring daily adjustments. As shown, in one example of an embodiment, theprecise adjustment mechanism 300 includes a body 310, a plunger 320, anda spring 330. The precise adjustment mechanism 300 may be fixed to thestrut body 110 in a position that does not interfere with the adjustmentscale and, in one embodiment, may be positioned underneath the threadedcollar 250 as generally shown in FIGS. 1A-1C. In use, the spring 330biases the plunger 320 so that the plunger 320 extends beyond an outeredge of the body 310 and into the cavity 252 of the threaded collar 250.Thus arranged, the precise adjustment mechanism 300 cannot turn as longas the plunger 320 is positioned within the cavity 252 of the threadedcollar 250. Moving the plunger 320 from its first position to a secondposition so that the plunger 320 no longer engages the threaded collar250 allows the precise adjustment mechanism 300 to be turned, advancingor retrieving the threaded rod 120 relative to the strut body 110 andhence adjusting the length of the external fixation strut 100. Thenumber and spacing of cavities 252 in the base of the threaded collar250 defines the resolution of precise adjustment. For example, fourequally spaced cavities 252 with an assembly that advances onemillimeter per full turn provides tactile feel and hard stops everyquarter of a turn of adjustment, which are one-quarter millimeter linearadjustment increments. When fully assembled, the threaded collar 250turns with the actuator body 210 as one assembly. In other embodiments,the body 310, or a similar component, may be coupled to the strut bodyand notches, openings, or other mechanisms may be located on theactuator body.

In one example of an embodiment, as will be described in greater detail,the external fixation struts 100 may be coupled to first and secondrings, bases, etc. (used interchangeably without the intent to limit),as will be appreciated by one of ordinary skill in the art. The externalfixation struts 100 may be coupled to the bases by any suitableconnectors, mechanisms, or the like now known or hereafter developed.For example, referring to FIGS. 7A and 7B, U-joints 500 may be used.Alternatively however, as previously mentioned, any other now known orhereafter developed connector can be used such as, for example, balljoints, threaded ends, etc. In one example of an embodiment, each of theU-joints 500 may be constructed of two joint devises 510, 512, a centralbody 514, and set screws 516. The set screws 516 connect the centralbody 514 to the joint devises 510, 512 and reduce the slope of thejoints. That is, one or more of the U-joints for coupling the externalfixator struts may include first and second clevis components 510, 512,each clevis component 510, 512 having a threaded bore for receiving afastener for coupling the first and second clevis components 510, 512to, for example, the external fixator strut and the base, ring, etc. Inaddition, the one or more of the U-joints may include a central body orbushing 514 having a plurality of openings such as, for example,threaded openings for receiving a plurality of screws such as, forexample, set screws, ball end screws, etc. for coupling the central bodyor bushing 514 to the first and second clevis components 510, 512.

Alternative embodiments of the disengagement members, labelled 230′ and230″, are depicted in FIGS. 8A and 8B. The disengagement member 230′shown in FIG. 8A has angled exterior surfaces 239 so that bothdisengagement members 230′ may be depressed by portions of the rotatingsleeve 240 as the rotating sleeve 240 is rotated relative to theactuator body 210. As seen in FIG. 8B, the disengagement member 230″ maybe designed without the angled exterior surfaces, thus requiring thedisengagement members be depressed before the sleeve 240 can be rotatedrelative to the actuator body 210.

As shown in FIGS. 9A-9D, an alternative embodiment of the acuteadjustment mechanism may have an alternative actuator body 2210 with adifferent gripping surface and an alternative rotating sleeve 2240 withround openings 2260 rather than rectangular openings. The alternativeactuator body 2210 is shown in use with disengagement members 230″. InFIGS. 9A and 9B, the rotating sleeve 2240 is shown with its openings2260 aligned with disengagement members 230″ to allow the mobile jaws220 to be pushed against the spring bias and engaged with the threadedrod 120. As shown in FIGS. 9C and 9D, the rotating sleeve 2240 is movedrotationally to block outward travel of the disengagement members 230″and hold the disengagement members 230″ in a pushed state thatdisengages the mobile jaws 220 from the threaded rod 120.

Referring to FIG. 10, in one example of an embodiment, the externalfixation strut 100 may also include a locking sleeve 600. In use,incorporation of the locking sleeve 600 may assist with preventingaccidental adjustment for any of the fixation strut embodimentsdisclosed herein. In this embodiment of the locking sleeve, adjustmentwould be limited to motion of a tracer pin 610 with the locking sleeve600 coupled around the strut body 110. The locking sleeve 600 may beheld in place at the desired level with a bolt 620 that may be engagedwith the side of the strut body 110. This prevents the strut 100 fromadjusting but does not take up any adjustment range of the threaded rod120. That is, in one example of an embodiment, the a tracer pin 610 maybe operatively coupled to the threaded rod 120. The tracer pin 610 canbe coupled to the threaded rod 120 by any now known or hereafterdeveloped mechanism including, for example, adhesive, welding,fasteners, integrally formed, etc. The locking sleeve 600 may beoperatively and selectively coupled to the strut body 110 by any nowknown or hereafter developed mechanism such as, for example, bolt 620.The locking sleeve 600 includes an opening, cavity, or the like,arranged and configured to receive the tracer pin 610. In use, thelocking sleeve 600 is arranged and configured to prevent movement of thetrack pin 610 and thus to prevent adjustment of the external fixationstrut.

As previously mentioned, in use, the external fixation strut 100 may bea part of an external fixation system that includes an upper base, alower base, and multiple struts between the upper base and the lowerbase. At least one of the struts may be the external fixation strut 100or one of the other fixation struts disclosed herein. In someembodiments, the system includes six struts coupled between the upperbase and the lower base and at least one of the six struts is theexternal fixation strut 100, but in other embodiments may includesystems with fewer or more struts than six. Any of the struts describedherein may also include one or more telescoping bodies that translaterelative to one another to change the overall length of the strut. Thesystem may also include connectors for coupling with one or both of theupper base and the lower base. For example, the connectors may includethe universal joints 500 and further may include fasteners between theuniversal joints 500 and the bases. System embodiments may also includebone fixation mechanisms for coupling between the connectors or thebases and tissue of a patient. Such bone fixation mechanisms may be anynow known or hereafter developed bone fixation members including, forexample, wires (threaded and unthreaded), k-wires, pins, and screws.

Referring to FIGS. 11A-16, an alternate example of an embodiment of anexternal fixation strut 1100 is disclosed. As will be described herein,external fixation strut 1100 may be substantially similar to externalfixation strut 100 except as noted herein. As shown in the exampleembodiment, the external fixation strut 1100 includes a strut body 1110,a threaded rod 120 substantially rotationally fixed relative to thestrut body 1110 so that movement of the threaded rod 120 axiallytranslates or moves the threaded rod 120 relative to the strut body1110, an acute adjustment mechanism 1200 selectively disengageable fromthreads of the threaded rod 120, and a precise adjustment mechanism1300.

In one example of an embodiment, the acute adjustment mechanism 1200includes an actuator body 1210 that includes a threaded collar 1250(FIGS. 12 and 14B), a spring-loaded mobile jaw 1220 including associatedbiasing springs 1214, and one or more disengagement members 1230 thatare configured to interact with the mobile jaw 1220. The actuator body1210 includes one or more apertures 1216 (FIGS. 13C and 14A) to receiveat least a portion of the one or more disengagement members 1230,respectively (e.g., as shown, the acute adjustment mechanism 1200 mayinclude one disengagement member 1230 and one aperture 1216). Thedisengagement member 1230 may be in the form of shown is a buttoncapable of translation toward the center of the device and rotationabout its axis, but other embodiments are envisioned including, forexample, one or more wedges, screws, cams, or any other mechanism nowknown or hereafter developed.

In the illustrated embodiment, the threaded collar 1250 is arranged andconfigured to couple the actuator body 1210 to the strut body 1110. Inone example of an embodiment, the actuator body 1210 may include one ormore channels 1212 (FIG. 16) to guide the path of the mobile jaws 1220and the associated springs 1214. In use, the associated springs 1214bias the mobile jaws 1220 against the threaded rod 120 and toward thedisengagement member 1230. For example, the mobile jaws 1220 may includefaces 1222 that interact with surfaces 1232 of the disengagement member1230 so that when the disengagement member 1230 is pressed inward, themobile jaws 1220 move (e.g., separate and disengage) from the threadedrod 120 so that the strut length of the external fixation strut 1100 canbe adjusted acutely.

In one example of an embodiment, as shown, the precise adjustmentmechanism 1300 includes a body 1310, a pivot pin 1340, and a spring1330. The spring 1330 biases the body 1310 about the pivot pin 1340 toan engaged position toward a notch 1180 (FIG. 15C) in the strut body1110. In use, the actuator body 1210 is inhibited from moving (e.g.,turning) relative to the strut body 1110 as long as a portion of thebody 1310 is seated in the notch 1180.

In one example of an embodiment, as shown, the external fixation strut1100 may also include bands 1400, as described herein. In addition,and/or alternatively, the external fixation strut 1100 may also includeand one or more connectors 500 to couple the external fixation strut1100 to one or more bases. As shown, and as previously mentioned, theconnectors 500 may be in the form of a U-joint, alternatively howeverany other now known or hereafter developed connector can be used suchas, for example, ball joints, threaded ends, etc.

In the illustrated embodiment, the mobile jaws 1220 are biased to couplewith the threads of the threaded rod 120 by the springs 1214. The mobilejaws 1220 shown include threaded portions that interact with thethreaded rod 120, but in other embodiments, mobile jaws may includeother structure for interacting with the threaded rod including, forexample, knurling, a softer material, or any other structure or materialthat is capable of interacting with the threads of the threaded rod 120.In use, the mobile jaws 1220 are arranged and configured to interactwith the disengagement members 1230. For example, the mobile jaws 1220may include faces 1222 that interact with surfaces 1232 of thedisengagement member 1230. Aperture 1216 formed in the side of theactuator body 1210 may constrain the disengagement member 1230. In use,the disengagement member 1230 is designed so that it can be pressed fromoutside of the actuator body 1210 toward the threaded rod 120 so thatwhen the disengagement member 1230 is pressed inwards, the mobile jaws1220 disengage from the threaded rod 120 enabling the strut length ofthe external fixation strut 100 to be adjusted acutely. For example, inone embodiment, the geometry of the disengagement member 1230 inside ofthe actuator body 1210 may be shaped like a wedge, although othersuitable configurations are envisioned. The faces 1232 of this wedgeinteract with the faces 1222 of the mobile jaws 1220 so that when thedisengagement member 1230 is pressed inward, the mobile jaws 1220 move(e.g., separate and disengage) from the threaded rod 120 (FIGS. 13E-14B)enabling the threads to be disengaged and hence the strut length to beadjusted acutely. As shown in the progression between FIGS. 13D and 13Eand with the action arrows in FIG. 13E, the mobile jaws 1220 areconfigured to pivot away from the threaded rod 120 when sufficientlyinteracted with by the disengagement member 1230.

The mobile jaws 1220 may be constrained within the actuator body 1210 bythe channels 1212 (FIG. 16) so that pivoting toward and away from thethreaded rod 120 is accomplished along a designated path. As shown inthe progression between FIG. 13E and FIGS. 14A-14B, the disengagementmember 1230 is configured to be rotated about its longitudinal axis toengage tabs 1233 behind a portion of the actuator body 1210 when thedisengagement member 1230 has been pressed toward the threaded rod 120.By rotating multiple disengagement members on multiple external fixationstruts in this manner, multiple external fixation struts can be adjustedacutely at once because the user is not required to keep thedisengagement member 1230 depressed by hand.

As previously mentioned, the external fixation strut 1100 may alsoinclude a threaded collar 1250 (FIGS. 12 and 14B). In use, the threadedcollar 1250 connects the actuator body 1210 to the strut body 1110. Thethreaded collar 1250 may be slid up the base of the strut body 1110 andthreaded into the base of the actuator body 1210. As shown, the acuteadjustment mechanism 1200 may also include a first washer 1280 and asecond washer 1282 (FIG. 12). Washers 1280, 1282 (FIG. 12) may bepositioned between the threaded collar 1250 and the strut body 1110, andbetween the strut body 1110 and the actuator body 1210. The washers1280, 1282 act as spacers and reduce friction. The washer 1282 betweenthe strut body 1110 and the actuator body 1210 may also furtherconstrain the mobile jaws 1220 and disengagement member 1230. In theillustrated embodiment, the mobile jaws 1220 may be constrained withinthe acute adjustment mechanism 1200 by the channels 1212 (FIG. 16). Eachof the channels 1212 inside the actuator body 1210 may correspond to(e.g., match) a protrusion 1224 (FIGS. 14B, 15C, and 15E) on the top ofthe mobile jaws 1220. Thus arranged, rotation of the mobile jaws 1220 isguided toward and away from the threaded rod 120 and prevents the mobilejaws 1220 from moving out of position. Alternatively, jaws of someembodiments may have posts on the jaws that align with holes on theactuator body and the rotating sleeve.

Referring to FIGS. 12, 13A, and 15A, as previously mentioned, theexternal fixation strut 1100 may also include a band 1400. In someembodiments, bands 1400 may be arranged and configured as identification(ID) bands for identifying each particular strut in the externalfixation system. As such, the bands 1400 may be provided to numericallyidentify strut assemblies so that each strut assembly may bedistinguished for a prescription. In use, the bands 1400 are coupled tothe external fixation struts 1100. For example as shown, in one exampleof an embodiment, the bands 1400 may be slid down over the top of theactuator body 1210. Some embodiments of the band 1400 include pegs,projections, or other connection devices that are sized and configuredto be received by holes in an associated actuator body to couple thecomponents. The band 1400 provides a safety feature and reduces the riskof inadvertent acute adjustment of the strut assembly by limiting accessto the disengagement member 1230, making it more difficult toinadvertently depress. Acute adjustment generally takes place clinicallyduring application of the external fixation frame or during strutchange-outs. The bands 1400 may be helpful to avoid inadvertent acuteadjustment when a patient is adjusting struts using precise adjustmentmechanisms to comply with an adjustment prescription such as, forexample, when adjusting the struts at home utilizing the preciseadjustment mechanism to comply with the prescription.

Referring to FIGS. 15A-15E, the precise adjustment mechanism 1300 willbe described in greater detail. As will be described in greater detail,the precise adjustment mechanism 1300 enables the strut length of theexternal fixation struts 1100 to be adjusted. As noted above, the spring1330 biases the body 1310 about the pivot pin 1340 to an engagedposition toward the notch 1180 (FIGS. 15C and 15E) in the strut body1110. Thus arranged, the body 1310 cannot turn relative to the strutbody 1110 as long as a portion of the body 1310 is seated in the notch1180. Moving the body 1310 about the pivot pin 1340 in the direction ofthe action arrows in FIGS. 15D and 15E from a first position to a secondposition so that the body 1310 is no longer positioned in the notice1180 allows for the precise adjustment mechanism 1300 to be turned withthe acute adjustment mechanism 1200, advancing or retrieving thethreaded rod 120 (e.g., the acute and precise adjustment mechanisms1200, 1300 are fixed within the actuator body 1210. As such, when theactuator body turns to adjust small increments (e.g., via the preciseadjustment mechanism) the components of both mechanisms turn in unison).The number and spacing of the notches 1180 defines the resolution ofprecise adjustment. For example, four equally spaced notches 1180 withan assembly that advances one millimeter per full turn provides tactilefeel and hard stops every quarter of a turn of adjustment, which areone-quarter millimeter linear adjustment increments. When fullyassembled, the threaded collar 1250 (FIG. 14B) turns with the actuatorbody 1210 as one assembly. In other embodiments, the body 1310, or asimilar component, may be coupled to the strut body and notches,openings, or other mechanisms may be located on the actuator body.

Although not shown, the external fixation strut 1100 may also include alocking sleeve such as, for example, the locking sleeve 600 describedabove in association with FIG. 10. In use, incorporation of the lockingsleeve 600 may assist with preventing accidental adjustment. In thisembodiment, and as previously mentioned, adjustment would be limited tomotion of the tracer pin 610 with the locking sleeve 600 coupled aroundthe strut body 1110. The locking sleeve 600 may be held in place at thedesired level with the bolt 620 that may be engage with the side of thestrut body 1110. This prevents the strut from adjusting but does nottake up any adjustment range of the threaded rod 120.

The external fixation strut 1100 may be a part of an external fixationsystem that includes an upper base, a lower base, and multiple strutsbetween the upper base and the lower base. At least one of the strutsmay be the external fixation strut 1100 or one of the other fixationstruts disclosed herein. In some embodiments, the system includes sixstruts coupled between the upper base and the lower base and at leastone of the six struts is the external fixation strut 1100, but in otherembodiments may include systems with fewer or more struts than six. Anyof the struts described herein may also include one or more telescopingbodies that translate relative to one another to change the overalllength of the strut. The system may also include connectors for couplingwith one or both of the upper base and the lower base. For example, theconnectors may include the universal joints 500 and further may includefasteners between the universal joints 500 and the bases. Systemembodiments may also include bone fixation mechanisms for couplingbetween the connectors or the bases and tissue of a patient. Such bonefixation mechanisms may include wires (threaded and unthreaded),k-wires, pins, and screws, for example.

Referring to FIGS. 17-18D, an alternate example of an embodiment of anexternal fixation strut 3100 is disclosed. As will be described herein,external fixation strut 3100 may be substantially similar to externalfixation struts 100, 1100 except as noted herein. As shown, the externalfixation strut 3100 includes a strut body 1110, a threaded rod 120substantially rotationally fixed relative to the strut body 1110 so thatmovement of the threaded rod 120 axially translates or moves thethreaded rod 120 relative to the strut body 1110, an acute adjustmentmechanism 3200 selectively disengageable from threads of the threadedrod 120, and a precise adjustment mechanism such as, for example, theprecise adjustment mechanism 1300.

In one example of an embodiment, the acute adjustment mechanism 3200includes an actuator body 3210 that includes the threaded collar 1250(FIGS. 18B and 18D), a spring-loaded mobile jaw 3220, and one or moredisengagement members 3230 that are configured to interact with themobile jaw 3220. The disengagement member 3230 includes structurearranged and configured to interact with the mobile jaws 3220. Forexample, the disengagement members 3230 may include a structure with anarcuate surface 3232 (FIG. 18D) facing the mobile jaws 3220 configuredto move away from and toward the center of the device, but otherembodiments are envisioned including, for example, a disengagementmember including one or more wedges, screws, cams, or any othermechanism now known or hereafter developed.

In the illustrated embodiment, the external fixation struct 3100 mayinclude a threaded collar such as, for example, the threaded collar1250, to connect the actuator body 3210 to the strut body 1110. In oneexample of an embodiment, the actuator body 3210 may include one or morechannels to guide the path of the mobile jaws 3220. In the embodimentdepicted, each of the mobile jaws 3220 is hinged about a pin 1112 (FIGS.18B and 18D). The illustrated mobile jaws 3220 include torsion springs3221 (FIGS. 18B and 18D) that bias the mobile jaws 3220 away from thethreaded rod 120 and toward the disengagement member 3230. The mobilejaws 3220 have faces 3222 (FIG. 18D) that interact with the arcuatesurface 3232 of the disengagement member 3230 so that when thedisengagement member 3230 is allowed to move away from the center of thedevice (e.g., when the disengagement member is allowed to move the firstposition to the second position), the faces 3222 of the mobile jawspress against the arcuate surface 3232 and the mobile jaws 3220 move(e.g., separate and disengage) from the threaded rod 120 (FIGS. 18C and18D) so that the strut length of the external fixation strut 3100 can beadjusted acutely.

In one example of an embodiment, the precise adjustment mechanism may bethe precise adjustment mechanism 1300 previously described. Aspreviously described, the precise adjustment mechanism 1300 includes abody 1310, a pivot pin 1340, and a spring. The spring biases the body1310 about the pivot pin 1340 to an engaged position toward a notch 1180(FIGS. 18B and 18D) in the strut body 1110. The body 1310 cannot turnrelative to the strut body 1110 as long as a portion of the body 1310 isseated in the notch 1180.

In one example of an embodiment, the external fixation strut 3100 mayalso include bands 3400 (FIGS. 17, 18A, and 18C) as described herein. Inaddition, and/or alternatively the external fixation strut 3100 mayinclude and one or more connectors 500 to couple the external fixationstrut 3100 to one or more bases. As shown, and as previously mentioned,the connectors 500 may be in the form of a U-joint, alternativelyhowever any other now known or hereafter developed connector can be usedsuch as, for example, ball joints, threaded ends, etc. In someembodiments, the band 3400 may be considered a containment device thatis a component of the disengagement member that works in conjunctionwith the disengagement member 3230 to hold the disengagement member 3230toward the center of the device to cause the mobile jaws 3220 to engagewith the threaded rod 120 (e.g., the band/containment device arearranged and configured to hold the disengagement member in the firstposition so that the mobile jaws engage the threaded rod).

In use, the mobile jaws 3220 of this embodiment are both biased todecouple from the threads of the threaded rod 120 by the torsion springs3221. The mobile jaws 3220 shown include threaded portions that interactwith the threaded rod 120, but in other embodiments, mobile jaws mayinclude other structure for interacting with the threaded rod including,for example, knurling, a softer material, or any other structure ormaterial that is capable of interacting with the threads of the threadedrod 120. In use, the mobile jaws 3220 are arranged and configured tointeract with the disengagement member 3230. For example, the mobilejaws 3220 may include faces 3222 that interact with the arcuate surface3232 of the disengagement member 3230. In use, the disengagement member3230 is designed so that it can be pressed toward the center of thedevice and toward the threaded rod 120 when the band 3400 is removed.The band 3400 may then be returned to position on the device, as shownin FIGS. 17 and 18A to keep the mobile jaws 3220 engaged with thethreaded rod 120 (e.g., to hold the disengagement member in the firstposition so that the mobile jaws engage the threaded rod).

As shown in the progression between FIGS. 18A and 18C and with theaction arrows in FIG. 18C, the mobile jaws 3220 are configured to pivotaway from the threaded rod 120 when the band 3400 is removed from thedevice and the disengagement member 3230 is allowed to move away fromthe center of the device (e.g., the mobile jaws 3220 are arranged andconfigured to move from a first position to a second position whereinthe mobile jaws move away (e.g., disengage) from the threaded rod 120when the band 3400 is removed from the device and the disengagementmember 3230 is allowed to move). Once the threads are disengaged, thestrut length can be adjusted acutely. As shown in the progressionbetween FIGS. 18A-18B and FIGS. 18C-18D, the disengagement member 3230is biased to a disengaged state in the absence of the band 3400. Byremoving multiple bands 3400 on multiple external fixation struts,multiple external fixation struts can be adjusted acutely at once on anexternal fixation system.

Band 3400 placement is depicted in FIGS. 17 and 18A. In someembodiments, bands 3400 may be arranged and configured as identification(ID) bands for identifying each particular strut in the externalfixation system. As such, the bands 3400 may be provided to numericallyidentify strut assemblies so that each strut assembly may bedistinguished for a prescription. The bands 3400 shown slide down overthe top of the actuator body 3210. In use, the bands 3400 are coupled tothe external fixation struts 3100. For example, as shown, in one exampleof an embodiment, the band 3400 include pegs, projections, or otherconnection devices that fit in holes in an associated actuator body tocouple the components. The band 3400 provides a safety feature andreduces the risk of inadvertent acute adjustment of the strut assemblyby limiting movement of the disengagement member 3230. As previouslymentioned, acute adjustment generally takes place clinically duringapplication of the external fixation frame or during strut change-outs.The bands 3400 may be helpful to avoid inadvertent acute adjustment whena patient is adjusting struts using precise adjustment mechanisms tocomply with an adjustment prescription.

Although not shown, the external fixation strut 3100 may also include alocking sleeve such as, for example, the locking sleeve 600 describedabove in association with FIG. 10. Use of such a device is an option forpreventing accidental adjustment.

The external fixation strut 3100 may be a part of an external fixationsystem that includes an upper base, a lower base, and multiple strutsbetween the upper base and the lower base. At least one of the strutsmay be the external fixation strut 3100 or one of the other fixationstruts disclosed herein. In some embodiments, the system includes sixstruts coupled between the upper base and the lower base and at leastone of the six struts is the external fixation strut 3100, but in otherembodiments may include systems with fewer or more struts than six. Anyof the struts described herein may also include one or more telescopingbodies that translate relative to one another to change the overalllength of the strut. The system may also include connectors for couplingwith one or both of the upper base and the lower base. For example, theconnectors may include the universal joints 500 and further may includefasteners between the universal joints 500 and the bases. Systemembodiments may also include bone fixation mechanisms for couplingbetween the connectors or the bases and tissue of a patient. Such bonefixation mechanisms may include wires (threaded and unthreaded),k-wires, pins, and screws, for example.

Referring to FIGS. 19-21B, an alternate example of an embodiment of anexternal fixation strut 4100 is disclosed. As will be described herein,external fixation strut 4100 may be substantially similar to externalfixation strut 100, 1100, 3100 except as noted herein. As shown, theexternal fixation strut 4100 includes a strut body 1110, a threaded rod120 substantially rotationally fixed relative to the strut body 1110 sothat movement of the threaded rod 120 axially translates or moves thethreaded rod 120 relative to the strut body 1110, an acute adjustmentmechanism 4200 selectively disengageable from threads of the threadedrod 120, and a precise adjustment mechanism such as, for example, theprecise adjustment mechanism 1300.

In one example of an embodiment, the acute adjustment mechanism 4200includes an actuator body 4210 that includes a threaded collar 1250(FIGS. 20D, 20E, and 20G), a spring-loaded mobile jaw 4220, and one ormore disengagement members 4230 that are configured to interact with themobile jaw 4220. The disengagement member 4230 may be in the form of abutton capable of translation toward the center of the device, but otherembodiments are envisioned including, for example, one or more wedges,screws, cams, or any other mechanism now known or hereafter developed.

In use, the threaded collar 1250 is arranged and configured to couplethe actuator body 4210 to the strut body 1110. In one example of anembodiment, the actuator body 4210 may include one or more channels toguide the path of the mobile jaws 4220. The device may include springsconfigured to bias the mobile jaws 4220 against the threaded rod 120 andtoward the disengagement member 4230. As shown in FIGS. 20E and 20G, themobile jaws 4220 may include faces 4222 that interact with surfaces 4232of the disengagement member 4230 so that when the disengagement member4230 is pressed inward, the mobile jaws 4220 move (e.g., are separateand disengage) from the threaded rod 120 so that the strut length of theexternal fixation strut 4100 can be adjusted acutely.

In one example of an embodiment, the precise adjustment mechanism may bethe precise adjustment 1300 previously described. As previouslydescribed, the precise adjustment mechanism 1300 includes a body 1310, apivot pin 1340, and a spring. The spring biases the body 1310 about thepivot pin 1340 to an engaged position toward a notch 1180 (FIGS. 20D,20E, and 20G) in the strut body 1110. In use, the body 1310 is inhibitedfrom moving (e.g., turning) relative to the strut body 1110 as long as aportion of the body 1310 is seated in the notch 1180.

In one example of an embodiment, the external fixation strut 4100 mayalso include bands 4400 as described herein. In addition, and/oralternatively, the external fixation strut 4100 may include one or moreconnector 500 to couple the external fixation strut 4100 to one or morebases. As shown, and as previously mentioned, the connectors 500 may bein the form of a U-joint, alternatively however any other now known orhereafter developed connector can be used such as, for example, balljoints, threaded ends, etc.

In use, in the illustrated embodiment, the mobile jaws 4220 are bothbiased to couple with the threads of the threaded rod 120 by the springsor other biasing mechanisms. For example, in one embodiment, the springscould be torsion springs that fit over either or both of the pins 1112,as shown in FIG. 18B, or any other effective biasing force member. Themobile jaws 4220 shown include threaded portions that interact with thethreaded rod 120, but other embodiments are envisioned including, forexample, knurling, a softer material, or any other structure or materialthat is capable of interacting with the threads of the threaded rod 120.In use, the mobile jaws 4220 are arranged and configured to interactwith the disengagement member 4230. For example, the mobile jaws 4220may include faces 4222 that interact with surfaces 4232 of thedisengagement member 4230. Aperture 4216 (FIGS. 20B and 20F) formed inthe side of the actuator body 4210 may constrain the disengagementmember 4230. In use, the disengagement member 4230 is designed so thatit can be pressed from outside of the actuator body 4210 toward thethreaded rod 120 (action arrow in FIG. 20F) so that when thedisengagement member 4230 is pressed inward (e.g., when thedisengagement member 4230 is moved from a first position to a secondposition), the mobile jaws 4220 disengage from the threaded rod 120enabling the strut length of the external fixation strut 4100 to beadjusted acutely. For example, in one embodiment, the geometry of thedisengagement member 4230 inside of the actuator body 4210 may be shapedlike a wedge, although other suitable configurations are envisioned. Thefaces of the wedge interact with the faces 4222 of the mobile jaws 4220so that when the disengagement member 4230 is pressed inward, the mobilejaws 4220 move (e.g., separate and disengage) from the threaded rod 120(FIGS. 20F and 20G) enabling the threads to disengage, and the strutlength to be adjusted acutely. In the embodiment shown, the mobile jaws4220 are configured to pivot away from the threaded rod 120 whensufficiently interacted with by the disengagement member 4230.

The mobile jaws 4220 may be constrained within the actuator body 4210 bychannels so that pivoting toward and away from the threaded rod 120 isaccomplished along a designated path. Control of the pivoting path mayalso or alternatively be directed by pivoting about respective pins 1112(FIGS. 20D, 20E, and 20G). As shown in FIG. 21A, and as will bedescribed in greater detail below, after the disengagement member 4230has been pressed toward the threaded rod 120, the disengagement member4230 may be held in this position by a temporary or acute band 4499positionable on the external fixation struts. By installing multipletemporary or acute bands 4499 on multiple external fixation struts inthis manner, multiple external fixation struts can be adjusted acutelyat once because the user is not required to keep the disengagementmembers 4230 depressed by hand, as will be described in greater detailbelow.

Band 4400 placement is depicted in FIGS. 19, 20A, and 20D. In someembodiments, bands 4400 may be arranged and configured as identification(ID) bands for identifying each particular strut in the externalfixation system. As such, the bands 4400 may be provided to numericallyidentify strut assemblies so that each strut assembly may bedistinguished for a prescription. The bands 4400 shown slide in and outfrom a side of the actuator body 4210, as shown in FIG. 20B, althoughother configurations are envisioned. In use, the bands 4400 are coupledto the external fixation struts 4100. For example, as shown, in oneexample of an embodiment, the band include pegs, projections, or otherconnection devices that fit in holes in an associated actuator body tocouple the components. For example, the illustrated band 4400 includesarms 4455 (FIGS. 20B, 20C, and 20D) configured to pass through slots4255 (FIGS. 20B and 20F) and engage with the mobile jaws 4220 within theactuator body to hold the mobile jaws 4220 against the threaded rod 120.

The band 4400 may also act as a safety feature by reducing the risk ofinadvertent acute adjustment of the strut assembly by limiting access tothe disengagement member 4230. For example, in the illustratedembodiment, the band 4400 is arranged and configured to fit over theactuator body 4210 without pushing, moving, activating, etc. thedisengagement member 4230. As such, the band 4400 is arranged andconfigured to engage the actuator body 4210 without activating thedisengagement member 4230 and thus preventing a patient from disengagingthe mobile jaws 4220 from the threaded rod 120. As shown, in theillustrated embodiment, the band 4400 includes a recess 4416 arrangedand configured to align with and receive the disengagement member 4230so that the disengagement member 4230 is received within the recess 4416when the band 4400 is coupled to the actuator body 4210 (e.g., therecess 4416 formed in the band 4400 allows the band 4400 to be fullyseated on the actuator body 4210 without pushing the disengagementmember (e.g., button) 4230). In use, the arms 4455 of the band 4400contact and fix the position of the mobile jaws 4220 therebyprohibiting, or at least minimizing, patient access to the disengagementmember (e.g., button) 4230 while band 4400 is coupled to the actuatorbody 4210. Thus arranged, the band 4400 makes it more difficult toinadvertently depress the disengagement member 4230. As previouslymentioned, acute adjustment generally takes place clinically duringinstallation of the external fixation frame or during strut change-outs.The bands 4400 may be helpful to avoid inadvertent acute adjustment whena patient is adjusting struts using precise adjustment mechanisms tocomply with an adjustment prescription.

As noted above, temporary or acute bands 4499 may be used to hold thedisengagement member 4230 in place during acute adjustment of a strut.That is, in contrast to the bands such as, for example, band 4400described above, the temporary or acute band 4499 shown in FIGS. 21A and21B are arranged and configured to ensure that the disengagement member(e.g., button) 4230 is activated, pressed, etc. Thus arranged, in use,surgeons can place, engage, etc. a temporary or acute band 4499 on eachstrut to change the length of a strut freely without having to push ineach disengagement member. In this way, surgeons can, for example, haveall six struts unlocked at once to adjust a frame acutely. In oneexample of an embodiment, this can be accomplished by providing atemporary or acute band 4499 without a recess. That is, by eliminatingthe recess 4416 from band 4400 that is sized and shaped to allow thedisengagement member 4230 to not be depressed when the band 4400 is inplace on the device, temporary or acute band 4499 contacts and activatesthe disengagement member 4230 when the temporary or acute band 4499 iscoupled to the actuator body. Respective temporary or acute bands 4499may have an essentially similar geometric configuration as compared tothe bands 4400, except for elimination of the recess 4416 and changes tothe arms 4455, and may have similar or the same respective size markingsor colorings as the bands 4400. Regarding changes to the arms, seetemporary arms 4465 in FIG. 21B that are shorter and more lateral and donot contact the mobile jaws 4220 sufficiently to press the mobile jaws4220 against the threaded rod 120. A lack of the recess 4416 is alsoevident in the view presented in FIG. 21B, as well as FIG. 21A.Embodiments of the temporary or acute bands 4499 may also include aretention structure, such as a tab 4488 shown in FIGS. 20C, 20D, and21B, useful in resisting inadvertent disengagement of the temporary oracute bands 4499 from an actuator body.

As previously mentioned, once the disengagement member 4230 has beenpressed toward the threaded rod 120, the disengagement member 4230 maybe held in this position by a temporary or acute band 4499. Byinstalling multiple temporary or acute bands 4499 on multiple externalfixation struts in this manner, multiple external fixation struts can beadjusted acutely at once because the user (e.g., surgeon during initialinstallation, strut change-out, etc.) is not required to individuallypress and hold each disengagement member 4230 in the pressed oractivated position. Referring to FIGS. 22A-22D, an alternate exampleembodiment of a temporary or acute band 4499′ is disclosed. Temporary oracute band 4499′ is substantially similar to temporary or acute band4499. In use, temporary or acute band 4499′ may be used in connectionwith an external fixator strut disclosed herein. In use, temporary oracute band 4499′ is arranged and configured to hold the disengagementmember such as, for example, disengagement member 4230 in place duringacute adjustment of the strut. In the illustrated embodiment, this canbe accomplished by eliminating the recess 4416 that is sized and shapedto allow band 4400 to be coupled to the external fixation strut withoutdepressing the disengagement member 4230 when the band is placed on thedevice. Respective temporary or acute bands 4499′ may have anessentially similar geometric configuration, except for elimination ofthe recess 4416 and changes to the arms 4455, and may have similar orthe same respective size markings or colorings as the bands 4400.Regarding changes to the arms, see temporary arms 4465′ that are shorterand more lateral and do not contact the mobile jaws 4220 sufficiently topress the mobile jaws 4220 against the threaded rod 120. A lack of therecess 4416 is also evident in the view presented in FIG. 22A.Embodiments of temporary or acute bands may also include a retentionstructure, such as a tab, useful in resisting inadvertent disengagementof the temporary or acute band from the actuator body.

Although not shown, the external fixation strut 4100 may also include alocking sleeve such as, for example, the locking sleeve 600 describedabove in association with FIG. 10. Use of such a device is an option forpreventing accidental adjustment.

The external fixation strut 4100 may be a part of an external fixationsystem that includes an upper base, a lower base, and multiple strutsbetween the upper base and the lower base. At least one of the strutsmay be the external fixation strut 4100 or one of the other fixationstruts disclosed herein. In some embodiments, the system includes sixstruts coupled between the upper base and the lower base and at leastone of the six struts is the external fixation strut 4100, but in otherembodiments may include systems with fewer or more struts than six. Anyof the struts described herein may also include one or more telescopingbodies that translate relative to one another to change the overalllength of the strut. The system may also include connectors for couplingwith one or both of the upper base and the lower base. For example, theconnectors may include the universal joints 500 and further may includefasteners between the universal joints 500 and the bases. Systemembodiments may also include bone fixation mechanisms for couplingbetween the connectors or the bases and tissue of a patient. Such bonefixation mechanisms may include wires (threaded and unthreaded),k-wires, pins, and screws, for example.

An embodiment of the invention is a method of adjusting an externalfixation strut, such as the external fixation struts 100, 1100, 4100.Such a method may include disengaging an acute adjustment mechanism 200,1200, 4200 of the external fixation strut 100, 1100, 4100 from threadsformed on a threaded rod 120 of the external fixation strut 100, 1100,4100. The acute adjustment mechanism 200, 1200, 4200 may be biasedtoward an engaged state in some illustrated embodiments. The threadedrod 120 may be substantially rotationally fixed relative to a strut body110, 1110 of the external fixation strut 100, 1100, 4100 so thatmovement of the threaded rod 120 axially translates or moves thethreaded rod 120 relative to the strut body 110, 1110. In someembodiment, the threaded rod 120 may be substantially rotationally fixedrelative to a strut body 110, 1110 of the external fixation strut 100,1100, 4100 by, for example, the tracer pin 610 shown in FIG. 10. In theillustrated embodiments, disengaging the acute adjustment mechanism 200,1200, 4200 of the external fixation strut 100, 1100 from threads formedon the threaded rod 120 includes moving mobile jaws 220, 1220, 4220 fromthe threaded rod 120. For example, disengaging the acute adjustmentmechanism 200, 1200, 4200 may include separating two substantiallyoppositely positioned mobile jaws 220, 1220, 4220 from one another.Referring to FIGS. 1A-10, in the embodiment shown with mobile jaws 220,separating the two substantially oppositely positioned mobile jaws 220includes moving (e.g., translating) the mobile jaws 220 away from thethreaded rod 120. In this embodiment, the two substantially oppositelypositioned mobile jaws 220 are moved by forcing the disengagementmembers 230 into contact with both of the mobile jaws 220, as shown bythe action arrows in FIG. 3F.

Referring to FIGS. 11A-16 and 19-21B, in the embodiments shown withmobile jaws 1220 and 4220 respectively, separating the two substantiallyoppositely positioned mobile jaws 1220, 4220 includes moving (e.g.,rotating) the mobile jaws 1220, 4220 away from the threaded rod 120. Inthese embodiments, the two substantially oppositely positioned mobilejaws 1220, 4220 are moved by forcing the disengagement member 1230, 4230into contact with both of the mobile jaws 1220, 4220, as shown by theaction arrows in FIG. 13E and FIG. 20F. The opposite ends of the mobilejaws 1220 from the ends where the mobile jaws 1220 are contacted by thedisengagement member 1230 are configured to contact respective surfacesof the actuator body 1210 and pivot against those surfaces. The mobilejaws 4220 pivot about pins 1112 at their opposite ends from the endswhere the mobile jaws 4220 are contacted by the disengagement member4230.

Methods of adjusting the external fixation strut 100, 1100, 4100 mayalso include moving the acute adjustment mechanism 200, 1200, 4200relative to the threaded rod 120 to a position closer to a finaladjustment position while the acute adjustment mechanism 200, 1200, 4200is disengaged from the threaded rod 120. The movement may beaccomplished manually or by a force created by a motorized drive,pneumatics, hydraulics, or other effective force. The acute adjustmentmechanism 200, 1200, 4200 of the external fixation strut 100, 1100, 4100may then be engaged to the threads of the threaded rod 120 by removingforce against the bias toward an engaged state. For example, removinguser force may include removing force from the disengagement member 230,1230, 4230 as biased by their respective springs to the stateillustrated in FIGS. 9B, 13D, and 20E.

An embodiment of the invention is a method of adjusting an externalfixation strut, such as the external fixation strut 3100. Such a methodmay include disengaging an acute adjustment mechanism 3200 of theexternal fixation strut 3100 from threads of a threaded rod 120 of theexternal fixation strut 3100. The acute adjustment mechanism 3200 may bebiased toward a disengaged state. The threaded rod 120 shown issubstantially rotationally fixed relative to a strut body 1110 of theexternal fixation strut 3100 so that movement of the threaded rod 120axially translates or moves the threaded rod 120 relative to the strutbody 1110. In some embodiment, the threaded rod 120 may be substantiallyrotationally fixed relative to a strut body 1110 of the externalfixation strut 3100 by, for example, the tracer pin 610 shown in FIG.10. In the illustrated embodiment, disengaging the acute adjustmentmechanism 3200 of the external fixation strut 3100 from threads of athreaded rod 120 includes allowing the two substantially oppositelypositioned mobile jaws 3220 to separate. This may include allowing thedisengagement member 3230 to translate away from the threaded rod 120.Specifically, as shown in FIG. 18C, the disengagement member 3230 isallowed to translate away from the threaded rod 120 by removing the band3400 from the device.

In this state, the acute adjustment mechanism 3200 may be moved relativeto the threaded rod to a position closer to a final adjustment position.The movement may be accomplished manually or by a force created by amotorized drive, pneumatics, hydraulics, or other effective force. Theacute adjustment mechanism 3200 of the external fixation strut 1100 maythen be engaged to the threads of the threaded rod 120 by applying forceagainst the bias toward a disengaged state. For example, user force maybe applied against the disengagement member 3230.

In the embodiment illustrated in FIGS. 17-18D, engaging the acuteadjustment mechanism 3200 of the external fixation strut 3100 to thethreads of the threaded rod 120 includes applying force to thedisengagement member 3230 against the bias toward a disengaged state.The band 3400 may be placed over the actuator body 3210 of the acuteadjustment mechanism 3200 to keep the acute adjustment mechanism engagedwith the threads of the threaded rod 120.

Methods of adjusting the external fixation strut 100, 1100, 3100, 4100may also include releasing a lock of a precise adjustment mechanism 300,1300 that is configured to lock between the strut body 110, 1110 and theacute adjustment mechanism 200, 1200, 3200, 4200. For example, in theembodiment shown in FIGS. 1A-9D, the lock includes the plunger 320coupled to the strut body 110 through the body 310 of the preciseadjustment mechanism, and the plunger 320 is releasable from thecavities 252 in the threaded collar 250 that is part of the acuteadjustment mechanism 200 by translating the plunger 320 away from itslocked state in the cavity 252. Movement of the plunger 320 illustratedaway from its locked state includes overcoming the spring bias of thespring 330.

In the embodiments shown in FIGS. 11A-16, FIGS. 17-18D, and FIGS.19-21B, the lock includes the notches 1180 that are part of the strutbody 1110, and the body 1310 of the precise adjustment mechanism 1300coupled to the acute adjustment mechanism 1200, 3200, 4200 is releasablefrom the notches 1180 by pivoting the body 1310 of the preciseadjustment mechanism 1300 away from its locked state in the notch 1180.Movement of the body 1310 of the precise adjustment mechanism 1300 awayfrom its locked state includes overcoming the spring bias of the spring1330.

With the lock of the precise adjustment mechanism 300, 1300 in areleased state, another act of the method of adjusting the externalfixation strut 100, 1100, 3100, 4100 includes rotating the acuteadjustment mechanism 200, 1200, 3200, 4200 relative to the strut body110, 1110 to move the threaded rod 120 longitudinally relative to thestrut body 110, 1110. A result of such rotation is a lengthening orshortening of the external fixation strut 100, 1100, 3100, 4100 as maybe prescribed to achieve external fixation goals.

In some implementations, one end of the external fixation strut 100,1100, 3100, 4100 may be coupled to an upper base, and an opposite sendof the external fixation strut 100, 1100, 3100, 4100 may be coupled to alower base. In such a configuration, the act of rotating the acuteadjustment mechanism 200, 1200, 3200, 4200 relative to the strut body110, 1110, as detailed above, moves the upper base relative to the lowerbase. In some embodiments, implementation may include coupling one endof each of six external fixation struts 100, 1100, 3100, 4100 to anupper base and an opposite end of each of the six external fixationstruts 100, 1100, 3100, 4100 to a lower base. In such embodiments,rotating the acute adjustment mechanism 200, 1200, 3200, 4200 of each ofthe six external fixation struts 100, 1100, 3100, 4100 relative to itsrespective strut body 110, 1110 moves the upper base relative to thelower base.

Various embodiments of a system wholly or its components individuallymay be made from any biocompatible material. Instruments that will notbe implanted and remain in a patient may not necessarily bebiocompatible. For example and without limitation, materials may includein whole or in part: non-reinforced polymers, reinforced polymers,metals, ceramics, adhesives, reinforced adhesives, and combinations ofthese materials. Reinforcing of polymers may be accomplished withcarbon, metal, or glass or any other effective material. Examples ofbiocompatible polymer materials include polyamide base resins,polyethylene, Ultra High Molecular Weight (UHMW) polyethylene, lowdensity polyethylene, polymethylmethacrylate (PMMA),polyetheretherketone (PEEK), polyetherketoneketone (PEKK), a polymerichydroxyethylmethacrylate (PHEMA), and polyurethane, any of which may bereinforced. Example biocompatible metals include stainless steel andother steel alloys, cobalt chrome alloys, zirconium, oxidized zirconium,tantalum, titanium, titanium alloys, titanium-nickel alloys such asNitinol, and other superelastic or shape-memory metal alloys.

In one example of an embodiment, an external fixation strut isdisclosed, the external fixation strut comprising: a strut body; athreaded rod substantially rotationally fixed relative to the strutbody; an acute adjustment mechanism selectively disengageable fromthreads of the threaded rod, the acute adjustment mechanism comprising:an actuator body, a mobile jaw that is engageable with threads of thethreaded rod, and a disengagement member configured to interact with themobile jaw to disengage the mobile jaw from the threads of the threadedrod.

In another example of an embodiment, an external fixation system isdisclosed. The external fixation system comprising: an upper base; alower base; and at least two struts coupled between the upper base andthe lower base, at least one of the struts comprising: a strut body; athreaded rod substantially rotationally fixed relative to the strutbody; an acute adjustment mechanism selectively disengageable fromthreads of the threaded rod, the acute adjustment mechanism comprising:an actuator body, a mobile jaw that is engageable with threads of thethreaded rod, and a disengagement member configured to interact with themobile jaw to disengage the mobile jaw from the threads of the threadedrod.

In these and other embodiments, the external fixation strut may furthercomprise a precise adjustment mechanism comprising a lock between thestrut body and the actuator body; wherein the lock is biased to fix thestrut body with the actuator body rotationally, but may be activated toallow for rotation of the actuator body relative to the strut body tomove the threaded rod longitudinally relative to the strut body.

In these and other embodiments, the lock of the precise adjustmentmechanism includes a base coupled to the strut body, a plunger biasedaway from the base, and a cavity in the actuator body sized to receivethe plunger to restrict rotational movement of the strut body relativeto the actuator body.

In these and other embodiments, the lock of the precise adjustmentmechanism includes a pivot coupled to the actuator body with a portionbiased toward the strut body configured to fit in a notch in the strutbody to restrict rotational movement of the strut body relative to theactuator body when the portion is in the notch in the strut body.

In these and other embodiments, the mobile jaw may include a threadedsurface configured to engage with threads of the threaded rod.

In these and other embodiments, the acute adjustment mechanism mayinclude two substantially oppositely positioned mobile jaws configuredto engage with threads of the threaded rod on substantially oppositesides of the threaded rod.

In these and other embodiments, the substantially oppositely positionedmobile jaws each include a threaded surface configured to engage withthreads of the threaded rod.

In these and other embodiments, the mobile jaw is biased to engage withthe threaded rod.

In these and other embodiments, the mobile jaw is biased to disengagefrom the threaded rod.

In these and other embodiments, the disengagement member is a buttonconfigured to interact with the mobile jaw to disengage the mobile jawfrom the threads of the threaded rod when the button is moved by a user.

In these and other embodiments, the button includes an angled faceconfigured to interact with one or more faces of the mobile jaw todisengage the mobile jaw from the teeth of the threaded rod.

In these and other embodiments, the button includes a rounded faceconfigured to interact with one or more faces of the mobile jaw todisengage the mobile jaw away from the threaded rod.

In these and other embodiments, the disengagement member is configuredto translate toward the mobile jaw to disengage the mobile jaw from thethreaded rod and to be rotated about the disengagement member's axis oftranslation to lock the acute adjustment mechanism in a state of freemovement where the mobile jaw is disengaged from the threaded rod.

In these and other embodiments, the disengagement member is configuredto translate away from the mobile jaw to enable the mobile jaw todisengage from the threaded rod.

In these and other embodiments, the disengagement member includes acontainment device configured to prevent the mobile jaw from moving awayfrom the threads of the threaded rod when the containment device iscoupled to the acute adjustment mechanism.

In these and other embodiments, the containment device is arranged andconfigured as an ID band.

In these and other embodiments, the mobile jaw is configured totranslate away from the threaded rod when interacted with by thedisengagement member.

In these and other embodiments, the mobile jaw is configured to pivotaway from the threaded rod when interacted with by the disengagementmember.

In these and other embodiments, the actuator body includes a threadedcollar that couples the actuator body with the strut body.

In these and other embodiments, the actuator body includes channelsconfigured to guide the movement of the mobile jaw when the mobile jawis interacted with the disengagement member.

In these and other embodiments, the actuator body includes channelsconfigured to constrain the movement of protrusions on the mobile jawwhen the mobile jaw is interacted on by the disengagement member.

In these and other embodiments, the mobile jaw has one or more angledfaces configured to interact with the disengagement member to move themobile jaw away from the threaded rod.

In these and other embodiments, the external fixation strut may alsoinclude a rotatable sleeve that is sized to fit over the outside of theactuator body with one or more openings for access to the disengagementmember.

In these and other embodiments, when the rotatable sleeve is rotatedrelative to the actuator body, access to the disengagement member isblocked.

In these and other embodiments, when the rotatable sleeve is rotatedrelative to the actuator body a portion of opening interacts with thedisengagement member to disengage the mobile jaw from the threaded rod.

In these and other embodiments, the actuator body includes openings forprojections of a band to prevent disengagement of the mobile jaw fromthe threaded rod.

In these and other embodiments, a band covers the disengagement memberwhen the band is positioned on the acute adjustment mechanism to preventaccess to the disengagement member.

In these and other embodiments, the external fixation strut may alsoinclude connectors for coupling with one or both of the upper base andthe lower base.

In these and other embodiments, the external fixation struct may alsoinclude bone fixation mechanisms for coupling between the connectors andtissue of a patient.

In another example of an embodiment, a method of adjusting an externalfixation strut is disclosed. The method comprising: disengaging an acuteadjustment mechanism of the external fixation strut from threads of athreaded rod of the external fixation strut, wherein the acuteadjustment mechanism is biased toward an engaged state, and wherein thethreaded rod is substantially rotationally fixed relative to a strutbody of the external fixation strut; moving the acute adjustmentmechanism relative to the threaded rod to a position closer to a finaladjustment position; and engaging the acute adjustment mechanism of theexternal fixation strut to the threads of the threaded rod by removingforce against the bias toward an engaged state.

In another example of an embodiment, a method of adjusting an externalfixation strut is disclosed. The method comprising: disengaging an acuteadjustment mechanism of the external fixation strut from threads of athreaded rod of the external fixation strut, wherein the acuteadjustment mechanism is biased toward a disengaged state, and whereinthe threaded rod is substantially rotationally fixed relative to a strutbody of the external fixation strut; moving the acute adjustmentmechanism relative to the threaded rod to a position closer to a finaladjustment position; and engaging the acute adjustment mechanism of theexternal fixation strut to the threads of the threaded rod by applyingforce against the bias toward a disengaged state.

In these and other embodiments, the method may further comprisereleasing a lock of a precise adjustment mechanism that is configured tolock between the strut body and the acute adjustment mechanism; whereinwith the lock of the precise adjustment mechanism in a released state,rotating the acute adjustment mechanism relative to the strut body tomove the threaded rod longitudinally relative to the strut body.

In these and other embodiments, releasing the lock of the preciseadjustment mechanism includes overcoming a spring bias of the locktoward a locked state.

In these and other embodiments, releasing the lock of the preciseadjustment mechanism includes translating a lock component away from alocked state.

In these and other embodiments, releasing the lock of the preciseadjustment mechanism includes rotating a lock component away from alocked state.

In these and other embodiments, disengaging an acute adjustmentmechanism of the external fixation strut from threads of the threadedrod of the external fixation strut includes separating two substantiallyoppositely positioned mobile jaws.

In these and other embodiments, separating the two substantiallyoppositely positioned mobile jaws includes moving a disengagement memberinto contact with both of the mobile jaws.

In these and other embodiments, separating the two substantiallyoppositely positioned mobile jaws includes translating the twosubstantially oppositely positioned mobile jaws away from the threadedrod.

In these and other embodiments, separating the two substantiallyoppositely positioned mobile jaws includes pivoting the twosubstantially oppositely positioned mobile jaws away from the threadedrod.

In these and other embodiments, disengaging an acute adjustmentmechanism of the external fixation strut from threads of the threadedrod of the external fixation strut includes allowing two substantiallyoppositely positioned mobile jaws to separate.

In these and other embodiments, allowing the two substantiallyoppositely positioned mobile jaws to separate includes allowing adisengagement member to translate away from the threaded rod.

In these and other embodiments, allowing the two substantiallyoppositely positioned mobile jaws to separate includes removing a bandfrom the disengagement member.

In these and other embodiments, the method may further comprise couplingone end of the external fixation strut to an upper base and an oppositeend of the external fixation strut to a lower base, and wherein rotatingthe acute adjustment mechanism relative to the strut body moves theupper base relative to the lower base.

In these and other embodiments, the method may further comprise couplingone end of each of six external fixation struts to an upper base and anopposite end of each of the six external fixation struts to a lowerbase, and wherein rotating the acute adjustment mechanism of each of thesix external fixation struts relative to its respective strut body movesthe upper base relative to the lower base.

Terms such as closer, underneath, over, around, medial, lateral, inside,outside and the like have been used relatively herein. However, suchterms are not limited to specific coordinate orientations, distances, orsizes, but are used to describe relative positions referencingparticular embodiments. Such terms are not generally limiting to thescope of the claims made herein. Any embodiment or feature of anysection, portion, or any other component shown or particularly describedin relation to various embodiments of similar sections, portions, orcomponents herein may be interchangeably applied to any other similarembodiment or feature shown or described herein.

The foregoing description has broad application. While embodiments ofthe invention have been illustrated and described in detail in thedisclosure, the disclosure is to be considered as illustrative and notrestrictive in character. All changes and modifications that come withinthe spirit of the invention are to be considered within the scope of thedisclosure. Accordingly, the discussion of any embodiment is meant onlyto be explanatory and is not intended to suggest that the scope of thedisclosure, including the claims, is limited to these examples. In otherwords, while illustrative embodiments of the disclosure have beendescribed in detail herein, it is to be understood that the inventiveconcepts may be otherwise variously embodied and employed, and that theappended claims are intended to be construed to include such variations,except as limited by the prior art.

The foregoing discussion has been presented for purposes of illustrationand description and is not intended to limit the disclosure to the formor forms disclosed herein. For example, various features of thedisclosure are grouped together in one or more aspects, embodiments, orconfigurations for the purpose of streamlining the disclosure. However,it should be understood that various features of the certain aspects,embodiments, or configurations of the disclosure may be combined inalternate aspects, embodiments, or configurations.

The phrases “at least one”, “one or more”, and “and/or”, as used herein,are open-ended expressions that are both conjunctive and disjunctive inoperation. For example, each of the expressions “at least one of A, Band C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “oneor more of A, B, or C” and “A, B, and/or C” means A alone, B alone, Calone, A and B together, A and C together, B and C together, or A, B andC together.

The term “a” or “an” entity, as used herein, refers to one or more ofthat entity. As such, the terms “a” (or “an”), “one or more” and “atleast one” can be used interchangeably herein. The use of “including,”“comprising,” or “having” and variations thereof herein is meant toencompass the items listed thereafter and equivalents thereof as well asadditional items. Accordingly, the terms “including,” “comprising,” or“having” and variations thereof are open-ended expressions and can beused interchangeably herein.

All directional references (e.g., proximal, distal, upper, lower,upward, downward, left, right, lateral, longitudinal, front, back, top,bottom, above, below, vertical, horizontal, radial, axial, clockwise,and counterclockwise) are only used for identification purposes to aidthe reader's understanding of the present disclosure, and do not createlimitations, particularly as to the position, orientation, or use ofthis disclosure. Connection references (e.g., attached, coupled,connected, and joined) are to be construed broadly and may includeintermediate members between a collection of elements and relativemovement between elements unless otherwise indicated. As such,connection references do not necessarily infer that two elements aredirectly connected and in fixed relation to each other. Identificationreferences (e.g., primary, secondary, first, second, third, fourth,etc.) are not intended to connote importance or priority but are used todistinguish one feature from another. The drawings are for purposes ofillustration only and the dimensions, positions, order and relativesizes reflected in the drawings attached hereto may vary.

The invention claimed is:
 1. An external fixation strut comprising: astrut body operatively associated with a first connector; a threaded rodincluding threads formed thereon, the threaded rod being operativelyassociated with a second connector, the threaded rod being rotationallyfixed relative to the strut body so that movement of the threaded rodrelative to the strut body moves the first connector relative to thesecond connector; and an acute adjustment mechanism selectivelydisengageable from the threads of the threaded rod, the acute adjustmentmechanism comprising: an actuator body, a mobile jaw that is engageablewith the threads of the threaded rod, and a disengagement memberconfigured to interact with the mobile jaw to disengage the mobile jawfrom the threads of the threaded rod; wherein the disengagement memberis selectively movable from a first position to a second position suchthat when in the second position, the disengagement member interactswith the mobile jaw to disengage the mobile jaw from the threads of thethreaded rod to enable the first and second connectors to be adjustedacutely; and wherein the external fixation strut further comprises aband arranged and configured to cover the disengagement member when theband is coupled to the actuator body to prevent access to thedisengagement member to prevent movement of the disengagement memberfrom the first position to the second position.
 2. The external fixationstrut of claim 1, wherein the mobile jaw includes a threaded surfaceconfigured to engage with the threads of the threaded rod.
 3. Theexternal fixation strut of claim 1, wherein the acute adjustmentmechanism includes two substantially oppositely positioned mobile jawsconfigured to engage with threads of the threaded rod on substantiallyopposite sides of the threaded rod.
 4. The external fixation strut ofclaim 3, wherein the substantially oppositely positioned mobile jawseach include a threaded surface configured to engage with threads of thethreaded rod.
 5. The external fixation strut of claim 1, wherein themobile jaw is biased to engage with the threaded rod.
 6. The externalfixation strut of claim 1, wherein the disengagement member is a buttonconfigured to interact with the mobile jaw to disengage the mobile jawfrom the threads of the threaded rod when the button is moved by a userfrom the first position to the second position.
 7. The external fixationstrut of claim 1, wherein: the disengagement member is configured totranslate toward the mobile jaw when moved from the first position tothe second position to disengage the mobile jaw from the threaded rod;and the disengagement member is configured to rotate about an axis oftranslation of the disengagement member to lock the acute adjustmentmechanism in a state of free movement where the mobile jaw is disengagedfrom the threaded rod.
 8. The external fixation strut of claim 1,wherein the disengagement member is configured to translate away fromthe mobile jaw when moved from the first position to the second positionto enable the mobile jaw to disengage from the threaded rod.
 9. Theexternal fixation strut of claim 1, wherein the mobile jaw is configuredto translate away from the threaded rod when interacted with by thedisengagement member.
 10. The external fixation strut of claim 1,wherein the mobile jaw is configured to pivot away from the threaded rodwhen interacted with by the disengagement member.
 11. The externalfixation strut of claim 1, wherein the actuator body includes a threadedcollar that couples the actuator body with the strut body.
 12. Theexternal fixation strut of claim 1, wherein the actuator body includeschannels configured to guide the movement of the mobile jaw when themobile jaw is interacted with by the disengagement member.
 13. Theexternal fixation strut of claim 1, wherein the actuator body includeschannels configured to constrain the movement of protrusions on themobile jaw when the mobile jaw is interacted on by the disengagementmember.
 14. The external fixation strut of claim 1, further comprising aprecise adjustment mechanism comprising a lock positioned between thestrut body and the actuator body; wherein the lock is movable between afirst position and a second position, in the first position, the lock isarranged and configured to rotationally fix the strut body relative tothe actuator body, in the second position, the lock is arranged andconfigured to enable rotation of the actuator body relative to the strutbody to move the threaded rod longitudinally relative to the strut body.15. The external fixation strut of claim 14, wherein the lock of theprecise adjustment mechanism includes: a base coupled to the strut body;a plunger biased away from the base; and a cavity formed in the actuatorbody, the cavity arranged and configured to receive the plunger torestrict rotational movement of the strut body relative to the actuatorbody.
 16. The external fixation strut of claim 14, wherein the lock ofthe precise adjustment mechanism includes: a pivot coupled to theactuator body, the pivot being biased toward the strut body and beingarranged and configured to fit in a notch formed in the strut body torestrict rotational movement of the strut body relative to the actuatorbody when a portion of the pivot is positioned in the notch in the strutbody.
 17. The external fixation strut of claim 1, wherein the actuatorbody includes openings for projections of the band to preventdisengagement of the mobile jaw from the threaded rod.
 18. The externalfixation strut of claim 1, wherein the first and second connectors arefirst and second U-joints, respectively, the first and second U-jointsincluding: first and second devises; a central body having a pluralityof threaded openings; and a plurality of set screws arranged andconfigured to couple the central body to the first and second jointdevises.
 19. The external fixation strut of claim 1, further comprising:a tracer pin operatively coupled to the threaded rod; and a lockingsleeve operatively coupled to the strut body, the locking sleeveincluding an opening arranged and configured to receive the tracer pin,the locking sleeve being arranged and configured to prevent movement ofthe tracer pin and thus to prevent adjustment of the external fixationstrut.
 20. An external fixation strut comprising: a strut bodyoperatively associated with a first connector; a threaded rod includingthreads formed thereon, the threaded rod being operatively associatedwith a second connector, the threaded rod being rotationally fixedrelative to the strut body so that movement of the threaded rod relativeto the strut body moves the first connector relative to the secondconnector; and an acute adjustment mechanism selectively disengageablefrom the threads of the threaded rod, the acute adjustment mechanismcomprising: an actuator body, a mobile jaw that is engageable with thethreads of the threaded rod, a disengagement member configured tointeract with the mobile jaw to disengage the mobile jaw from thethreads of the threaded rod; and a rotatable sleeve that is sized to fitover the outside of the actuator body with one or more openings foraccess to the disengagement member, wherein the disengagement member isselectively movable from a first position to a second position such thatwhen in the second position, the disengagement member interacts with themobile jaw to disengage the mobile jaw from the threads of the threadedrod to enable the first and second connectors to be adjusted acutely.21. The external fixation strut of claim 20, wherein when the rotatablesleeve is rotated relative to the actuator body, access to thedisengagement member is blocked.
 22. The external fixation strut ofclaim 21, wherein when the rotatable sleeve is rotated relative to theactuator body, a portion of the one or more openings interact with thedisengagement member to disengage the mobile jaw from the threaded rod.23. An external fixation strut comprising: a strut body operativelyassociated with a first connector; a threaded rod including threadsformed thereon, the threaded rod being operatively associated with asecond connector, the threaded rod being rotationally fixed relative tothe strut body so that movement of the threaded rod relative to thestrut body moves the first connector relative to the second connector;and an acute adjustment mechanism selectively disengageable from thethreads of the threaded rod, the acute adjustment mechanism comprising:an actuator body, a mobile jaw that is engageable with the threads ofthe threaded rod, a disengagement member configured to interact with themobile jaw to disengage the mobile jaw from the threads of the threadedrod; and wherein the disengagement member is selectively movable from afirst position to a second position such that when in the secondposition, the disengagement member interacts with the mobile jaw todisengage the mobile jaw from the threads of the threaded rod to enablethe first and second connectors to be adjusted acutely, wherein theexternal fixation strut further comprises a temporary band arranged andconfigured to interact with the disengagement member to move the mobilejaw from the first position to the second position to disengage themobile jaw from the threaded rod when the temporary band is positionedon the acute adjustment mechanism.